Quiz 4 Flashcards

1
Q

It is impervious to air or any other gas under the ordinary or customary
conditions of handling, shipment, storage, and distribution

Tight container
Hermetic container
Well-closed container
Immediate container

A

Hermetic container

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2
Q

A term used to describe the movement of components of a container into
the contents
Leaching
Sorption
Oxidation
Permeability

A

Leaching

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3
Q

To ensure the stability of a pharmaceutical preparation for the period of
its intended shelf life, the product must be stored in proper condition

True
False

A

True

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4
Q

Common example of plastic materials used for drug production,
EXCEPT:

APET
PEG
PET
PETG

A

PEG

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5
Q

Deformations, softening, hardening and other physical changes in plastic
containers can be caused by the action of the container’s contents or
external factors, including temperature and the physical stress placed
upon the container in handling and shipping

True
False

A

True

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6
Q

Protects the contents from the contamination by extraneous liquids,
solids, or vapors, from loss of the article, and from efflorescence,
deliquescence, or evaporation under the ordinary or customary
conditions of handling, shipment, storage, and distribution and is capable
of tight re-closure

Hermetic container
Tight container
Immediate container
Well-closed container

A

Tight container

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7
Q

Highly resistant Boro silicate glass

A

Type I

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8
Q

General purpose soda lime glasss

A

NP

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9
Q

Soda lime glass

A

Type III

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10
Q

Treated soda lime glass

A

Type II

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11
Q

Protects the contents from extraneous solids and from loss of the article
under ordinary conditions of handling, shipment, storage, and distribution

Well-closed container
Hermetic container
Tight container
Immediate container

A

Well-closed containeer

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12
Q

Moisture barrier

A

Not GMP

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13
Q

Laboratory controls

A

GMP

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14
Q

Organization a personnel

A

GMP

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15
Q

Drug stability

A

Not GMP

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16
Q

Equipment

A

GMP

17
Q

Records and Reports

A

GMP

18
Q

Drug compatibility

A

Not gmp

19
Q

Packaging and labeling control

A

GMP

20
Q

Returned and salvaged drugs

A

GMP

21
Q

Sterility and permeation for parenteral

A

Not GMP

22
Q

Advantages of ng plastic containers, EXCEPT: *

Reduction of transportation cost and losses
Versatility in container design
Consumer preference
Heavy in weight and prone to impact

A

Heavy in weight and prone to impact

23
Q

Desiccant protectants, such as silica gel in small packets, are commonly
included as added protection against the effect of moisture vapor

True
False

A

True

24
Q

A decrease in temperature, pressure and use of additives tend to increase
the permeability of the plastic

True
False

A

Fals

25
Q

Above 40 C

A

Excessive heat

26
Q

Between 20 C and 25 C

A

Room temperature

27
Q

Between 30 C and 40 C

A

Warm

28
Q

Between 8 C and 15 C

A

Cool

29
Q

Not exceeding 8 C

A

Cold